Uni Eropa - Malta - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - vaċċin għal influwenza pandemika (h5n1) (virjon maqsum, mhux attivat, supplimentat) - influenza, human; immunization; disease outbreaks - vaċċini - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. pandemija tal-influwenza fil-vaċċin għandu jintuża skont il-gwida uffiċjali.

Uni Eropa - Malta - EMA (European Medicines Agency)

genzyme europe bv - mipomersen sodium - iperkolesterolemija - sistema kardjovaskulari - it-trattament tal-kolesterol u l-iperkolesterolimja,.

Uni Eropa - Malta - EMA (European Medicines Agency)

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - aġenti li jaġixxu fuq is-sistema renin-angiotensin - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Uni Eropa - Malta - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimetil fumarate - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Uni Eropa - Malta - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Uni Eropa - Malta - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narcolepsy - drogi oħra tas-sistema nervuża - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

Uni Eropa - Malta - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - aġenti antineoplastiċi oħra - removab huwa indikat għat-trattament intraperitoneali ta 'axxiti malinni f'pazjenti b'karċinomi pożittivi għal epcam fejn it-terapija standard mhijiex disponibbli jew m'għadhiex possibbli.

Uni Eropa - Malta - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - sindromu adh inappropriate - id-dijuretiċi, - trattament ta 'pazjenti adulti b'iponatrija sekondarja għal sindromu ta' sekrezzjoni mhux xierqa ta 'l-ormon antidijuretiku (siadh).

Uni Eropa - Malta - EMA (European Medicines Agency)

viatris healthcare limited - tolcapone - marda ta 'parkinson - kontra l-marda ta ' parkinson id-drogi, aġenti dopaminerġiċi oħra - tasmar hija indikata fil kombinazzjoni ma ' ticlopidine hydrochloride / benserazide jew ticlopidine hydrochloride / carbidopa għall-użu fil-pazjenti ma ticlopidine hydrochloride-responsivi idiopathic parkinson's marda u oxxillazzjonijiet vetturi bil-mutur, li naqas milli jirrispondi għal jew huma intolerant ta ' xulxin inibituri ta ' catechol-o-methyltransferase (comt). minħabba r-riskju ta potenzjalment fatali, ħsara fil-fwied akut, tasmar ma għandhomx jiġu kkunsidrati bħala l-ewwel linja ta 'trattament miżjud ma' levodopa / benserazide jew levodopa / carbidopa. peress li tasmar għandu jiġi użat biss flimkien ma 'levodopa / benserazide u b'levodopa / carbidopa, l-tagħrif preskritt individwalment għal dawn l-sustanzi ta' levodopa hija applikabbli għall-użu tagħhom flimkien ma ' tasmar.

Uni Eropa - Malta - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - sindromu adh inappropriate - id-dijuretiċi, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).